Surgical stabilizer and closure system

ABSTRACT

A system for stabilizing the heart via a helical needle, providing access to the interior of the heart via an introducer sheath, and forming a purse string suture using suture delivered by the helical needle. A helical needle projects distally from the device in a helical shape and terminates in a sharp distal tip. The helical needle is advanced into the heart wall, and is used to stabilize the heart and to pass a purse string suture through the heart tissue. An access port provides access to the interior of the heart via an opening passing through the heart wall in an area circumscribed by the helical needle. A length of suture may pass through the helical needle and exit at an opening at or near the needle distal tip. A free end of the length of suture may extend out of the distal tip and back into the hollow suture needle through the opening. The helical needle may have a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the helical needle.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 13/301,515, filed Nov. 21, 2011, which claims priority under 35U.S.C. §119 to U.S. Provisional Application Ser. No. 61/418,188, filedNov. 30, 2010. This application is related to U.S. Provisional PatentApplication No. 61/229,190 entitled “Surgical Puncture Cinch and ClosureSystem,” filed Jul. 28, 2009; to U.S. Provisional Patent Application No.61/252,114 entitled “Surgical Puncture Cinch and Closure System,” filedOct. 15, 2009; and to U.S. Utility patent application Ser. No.12/844,139, now U.S. Pat. No. 8,500,757, entitled “Surgical PunctureCinch and Closure System,” filed Jul. 27, 2010. The entire contents ofeach of these applications and patent are expressly incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates to methods and systems for performingprocedures on a heart, and more particularly to stabilizing the heart,accessing the heart interior via an opening in the heart wall, andclosing the opening in the heart wall.

BACKGROUND OF THE INVENTION

The heart is a hollow muscular organ of a somewhat conical form; it liesbetween the lungs in the middle mediastinum and is enclosed in thepericardium. The heart generally rests obliquely in the chest behind thebody of the sternum and adjoining parts of the rib cartilages, andtypically projects farther into the left than into the right half of thethoracic cavity so that about one-third is situated on the right andtwo-thirds on the left of the median plane. The heart is subdivided bysepta into right and left halves, and a constriction subdivides eachhalf of the organ into two cavities, the upper cavity being called theatrium, the lower the ventricle. The heart therefore consists of fourchambers; the right and left atria, and right and left ventricles, withone-way flow valves between respective atria and ventricles and at theoutlet from the ventricles.

Heart valve repair and/or replacement may be indicated when there is anarrowing of a native heart valve, commonly referred to as stenosis, orwhen the native valve leaks or regurgitates, such as when the leafletsare calcified. Repairing a valve may include reshaping the valve annulususing, e.g., an annuloplasty ring, and/or repairing/replacing chordaetendinae, and/or repairing valve leaflets. When replacing the valve, thenative valve may be excised and replaced with either a biologic or amechanical valve.

Conventional heart valve surgery is an open-heart procedure conductedunder general anesthesia, and is a highly invasive operation. The first2-3 days following surgery are usually spent in an intensive care unitwhere heart functions can be closely monitored. The average hospitalstay is between 1 to 2 weeks, with several more weeks to months requiredfor complete recovery.

In recent years, advancements in minimally-invasive surgery andinterventional cardiology have encouraged some investigators to pursuepercutaneous repair and/or replacement of heart valves. PercutaneousValve Technologies (“PVT”), formerly of Fort Lee, N.J. and now part ofEdwards Lifesciences of Irvine, Calif., has developed a plastically- orballoon-expandable stent integrated with a bioprosthetic valve. Thestent/valve device, now called the Edwards Sapien™ Heart Valve, isdeployed across the native diseased valve to permanently hold the valveopen, thereby alleviating a need to excise the native valve. The EdwardsSapien™ Heart Valve is designed for delivery with the RetroFlex™delivery system in a cardiac catheterization laboratory under localanesthesia using fluoroscopic guidance, thereby avoiding generalanesthesia and open-heart surgery.

Some researchers propose implanting prosthetic heart valves at the valveannulus using a direct-access transapical approach. See, e.g., U.S.Patent Publication No. 2006-0074484. For replacing an aortic valve,access can be gained via the left ventricular apex (LVA), which isdirected downward, forward, and to the left in the patient's chest (fromthe perspective of the patient). The apex typically lies behind thefifth left intercostal space (or between the fourth and fifth), 8 to 9cm from the mid-sternal line, and about 4 cm below and 2 mm to themedial side of the left mammary papilla. Access to the left ventriclemay therefore be attained through an intercostal incision positionedover the fifth left intercostal space. Such an approach is often termeda “mini-thoracotomy,” and lends itself to surgical operations on theheart carried out using one or more short tubes or “ports”-thus, theoperations are often referred to as “port-access” procedures.

Dehdashtian in U.S. Patent Publication No. 2007-0112422 discloses aport-access delivery system for transapical delivery of a prostheticheart valve including a balloon catheter having a steering mechanismthereon that passes through an access device such as an introducer. Thesurgeon forms a puncture in the apex with a needle, advances aguidewire, then a dilator, and finally the introducer. Purse stringsutures are pre-installed around the puncture to seal against bloodleakage around the various devices and provide a closure after theprocedure. During the procedure the doctor/assistant is able to applytension to the purse-string-suture, which prevents inadvertent bloodloss. After the deployment of the heart valve, the purse sting-suture isthen used to permanently close the opening of the heart by drawingconcentric tension on the suture ends, and tying a secure knot. Theaforementioned Edwards Sapien™ Heart Valve may be inserted transapicallywith the Ascendra™ delivery system, much like the system disclosed inDehdashtian.

Often, direct- or port-access techniques are conducted or proposed foroff-pump, aka “beating heart” procedures, in which the heart remainsbeating as opposed to the patient being placed on a cardiopulmonarybypass system. Challenges remain in stabilizing various instruments usedduring these procedures, as well as in stabilizing targeted patienttissues and/or organs. For example, a number of devices are availablethat directly contact the heart muscle for stabilizing an area around acardiac artery for coronary artery bypass graft (CABG) procedures. Thesesystems typically include a soft contact member having suction thatbrackets a coronary artery, or grabs and manipulates an area of theheart for better access. These systems are mostly concerned with holdingstill a discrete surface area of the heart for direct operation thereon,and are not designed for operations carried out by instruments thatextend within the beating heart, i.e., for intracardiac procedures.

What has been needed is a system and method for stabilizing the heartand the operating instruments, providing access to the heart interior,and sealing tissue punctures at the conclusion of the procedure. Thecurrent invention meets these needs.

SUMMARY OF THE INVENTION

The present application provides a system and method for stabilizing theheart (e.g., at its apex) and instruments used thereon, for accessingthe interior of the heart via a puncture or other opening in the heartwall, and for securely closing the puncture/opening in the heart wall atthe conclusion of the procedure. The invention may include delivery of aprosthetic (i.e., replacement) heart valve to a native valve site viaso-called keyhole surgery or other procedures conducted through theheart wall, with a purse string suture applied to the heart to seal thetissue around ports passed therethrough and/or to seal any punctures inthe heart wall. More broadly, the methods and systems described hereinmay be utilized in the context of various cardiac and other surgeriesthat benefit from stabilizing of body organs, accessing organ interiors,and using a purse string to effectuate closure of a puncture wound orsimilar opening.

One exemplary aspect of the invention is a method of stabilizing theheart, which can be conducted during a beating-heart procedure. Themethod includes providing a stabilizer having a generally helical needleat its distal end. The generally helical needle is advanced into thetissue of the heart wall, e.g., at the heart apex. The generally helicalneedle holds the heart apex against the stabilizer, which stabilizes theheart apex while still permitting the heart to beat.

A further exemplary aspect of the invention is a method of accessing theheart interior. A needle or similar puncture device (or other deviceconfigured to create an opening in the heart wall) is advanced throughthe stabilizer and through/into the heart wall, where the needle createsa puncture through the heart wall.

A further exemplary aspect of the invention is a method of forming aclosure at the site of puncture in the tissue. The method includesproviding the stabilizer with a length of suture in the handle. Thegenerally helical needle (used to secure the heart wall to thestabilizer) contains a free end of the length of suture. The helicalneedle has a distal portion projecting from the handle in a helicalshape and terminating in a sharp distal tip. The system furthercomprises a puncture needle extending from a distal end of thestabilizer substantially along an axis of the helical distal portion ofthe helical needle, the puncture needle having a sharp tip to puncturetissue. The method involves passing the puncture needle through thestabilizer to extend distally therefrom, and forming a puncture througha heart wall with the puncture needle. A user advances the suturestabilizer in screw-like fashion to thereby advance and rotate thehelical needle so that the sharp distal tip passes helically into tissuearound the puncture needle and continues at least 270° therearound. Afree end of a length of suture may directed out of the tissue andgrasped. The user then removes the puncture needle from the stabilizer,leaving the stabilizer (with helical needle) secured to the heart wall.The user then advances one or more surgical or other tools/devicesthrough the stabilizer and into the heart via the puncture created bythe puncture needle, and performs a procedure on the heart interiorusing the one or more surgical and/or other devices. After the procedurewithin the heart interior is completed, the one or more surgical and/orother devices are removed from the patient. The user then reversesrotation of the helical needle so that it retracts from the tissue whilethe length of suture remains within the heart wall through the generallyhelical path through the heart tissue and around the puncture. The usercan then grasp the opposing ends portions of the suture as they extendfrom the heart wall, and tighten the suture to form a purse-stringclosure about the puncture.

The handle of the stabilizer may have a chamber housing a suture spool,the length of suture being wound on the spool, whereby the methodfurther includes allowing the length of suture to play off the spoolwhen grasping the free end that emerges from the tissue and reversingrotation of the helical needle so that it retracts from the tissue. Thehelical needle may extend from a distal end of the stabilizer handle atpoints that are offset from a longitudinal axis of the handle. Thelongitudinal axis of the handle may be aligned with a helical axis ofthe helical portion of the helical suture needle. In one embodiment, thehelical suture needle extends from the handle at a point offset from thelongitudinal axis of the handle, while the puncture needle extends froma point generally aligned with the longitudinal axis of the handle.

The handle of the stabilizer may form and/or include an access portthrough which one or more instruments and/or other devices (implants,etc.) may be introduced into the heart interior (or the interior ofanother body organ to which the stabilizer is secured). The access portmay include a seal configured to prevent the unwanted passage of fluidthrough the port while still permitting the introduction and removal ofinstruments and/or other devices therethrough. The seal may beconfigured to engage against instruments passed through the access port,and to thereby restrain the instruments and/or prevent leakage aroundthe instruments through the access port.

In one embodiment, the helical needle includes a deflection segmentadjacent the distal tip that is more flexible than the rest of thehelical distal portion of the helical needle, and the method includesdeflecting the deflection segment in a proximal direction to direct thefree end of the length of suture back out of the tissue. Alternatively,the suture applicator may include an inner needle arranged to translatethrough the helical needle and extend from the distal tip thereof, andhaving a relaxed shape that conforms to the helical shape of the helicalneedle except at a distal end portion that has a proximal bend so thatit deflects in a proximal direction when extended from the distal tip ofthe helical needle. The method therefore includes translating the innerneedle along the helical needle so that the distal end portion extendsfrom the distal tip thereof and deflects in a proximal direction todirect the free end of the length of suture out of the tissue. The innerneedle may be hollow with the length of suture extending therethrough,with the method including deflecting the distal end portion of the innerneedle out of the tissue and grasping the free end of the length ofsuture.

In accordance with a specific application of the aforementioned method,the site of puncture is the apex of a ventricle, such as the leftventricle, and the method further includes installing a guidewirethrough the puncture needle into the ventricle. The user passes acardiac surgery device along the guidewire and into the ventricle andperforms a cardiac surgery with the cardiac surgery device. The userthen removes the cardiac surgery device from the heart and appliestension to the first and second free ends of the length of suture tocinch the heart wall tissue and close the puncture.

In one application, the site of puncture is the apex of the leftventricle, and the cardiac surgery device includes an introducer sheathcarrying a heart valve. In that case, the method may also includeperforming a heart valve replacement using the introducer sheathextending through the stabilizer device and the puncture, removing theintroducer sheath from the stabilizer device and the puncture, removingthe stabilizer, and tying the first and second free ends of the lengthof suture to form a purse string closure at the puncture.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a schematic frontal view of a patient showing the location ofan intercostal incision providing access to the apex of the leftventricle of the heart;

FIGS. 2A-2D are side, side (cross-sectional), front, and close-up viewsof a stabilizer device according to an embodiment of the invention;

FIG. 3A-3C side, side (cross-sectional), and front views of a puncturedevice according to an embodiment of the invention;

FIGS. 4A-4B are side and side (cross-sectional views) of a stabilizerdevice assembled with a puncture device according to an embodiment ofthe invention;

FIGS. 5A-5C are side cross-sectional views of a patient's heartdepicting securing the stabilizer device to the heart apex according toan embodiment of the invention;

FIG. 6 is a close-up view of the distal portion of a stabilizer deviceaccording to an embodiment of the invention;

FIG. 7 is a side cross-sectional view of a patient's heart depicting thestabilizer device secured to the heart apex according to an embodimentof the invention

FIGS. 8A-8D are cross-sectional views through the left side of apatient's heart showing deployment of a prosthetic heart valve via astabilizer device according to an embodiment of the invention;

FIGS. 9A-9B are cross-sectional views of a patient's chest cavitydepicting a stabilizer device and sheath being secured via a stabilizerplatform positioned on the outside of the patient according to anembodiment of the invention;

FIG. 10A depicts a perspective view of a stabilizer device beingwithdrawn from the heart wall according to an embodiment of theinvention; and

FIG. 10B is a front view of an apical puncture closed using sutureaccording to an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 depicts a cross-sectional view of a patient 10 where anintercostal incision opening 12 is created to access the patient's heart14. The heart is a hollow muscular organ of a somewhat conical form,positioned between the lungs in the middle mediastinum and enclosedwithin the pericardium. The heart rests obliquely in the chest behindthe body of the sternum and adjoining parts of the rib cartilages, andgenerally projects farther into the left than into the right half of thethoracic cavity so that about one-third is situated on the right andtwo-thirds on the left of the median plane. The heart is subdivided bysepta into right and left halves, and a constriction subdivides eachhalf of the organ into two cavities, the upper cavity being called theatrium, the lower the ventricle. The heart therefore consists of fourchambers; the right and left atria, and right and left ventricles.

As seen in FIG. 1, the left ventricular apex (aka LVA) 16 is directeddownward, forward, and to the left (from the perspective of thepatient). The left ventricular apex 16 typically lies behind the fifthleft intercostal space 18 (i.e., between the fifth and sixth ribs),generally 8 to 9 cm from the mid-sternal line, and about 4 cm below and2 mm to the medial side of the left mammary papilla. Access to the leftventricle may therefore be attained through the intercostal incision 12as shown in dashed line, positioned adjacent the fifth left intercostalspace 18. Such an approach is often termed a “mini-thoracotomy,” andlends itself to surgical operations on the heart carried out using oneor more short tubes or “ports”-thus, the operations are often referredto as “port-access” procedures.

FIGS. 2A-2D depict a stabilizer device 20 according to an embodiment ofthe invention. The device 20 includes a main body 22, which may act as ahandle as well as an access port. The main body 22 may be a generallyelongated and tubular member having a length 22L and outer diameter 22D.In one embodiment, the length 22L is about 2-4 inches, and the outerdiameter 22D is about 0.35-0.60 inches, although these dimensions areexemplary. The main body 22 may include an inner lumen 24 having adiameter 24D, which in one exemplary embodiment may be about 0.25-0.50inches.

The device 20 includes a generally helical needle 26 extending from thedistal end 27 of the main body 22. The helical needle 26 may be securedto the main body 22 via bonding or other techniques, and may be formedfrom a hypotube, e.g., a 18 gauge hypotube, formed to define a generallyhelical shape having a diameter 26D, wherein in one embodiment thediameter is in the range of about 20 mm-25 mm. In the particularembodiment depicted, a sharp detachable needle tip 28 is positioned atthe distal portion 29 of the helical needle 26. A line of suture 30passes from the main body 22 through the helical needle 26. A proximalportion 32 of the suture 30 is secured to the main body 22 (such as bybeing wrapped therearound or placed inside a cavity within the mainbody), and a distal portion 34 of the suture 30 is secured to thedetachable needle tip 28. The detachable needle tip 28 includes a sharpdistal point 36 and a crimped proximal portion 38, with the crimpedproximal portion 38 sized and shaped to fit relatively tightly into thedistal opening 40 of the helical needle 26 to form a smooth transitionfrom the helical needle 26 to the detachable needle tip 28. This willallow for smooth penetration of the helical needle 26 through thedesired tissue. In the embodiment depicted in FIGS. 2A-2C, the helicalneedle 26 includes a transition section 42 extending from the distal end27 of the main body 22. The transition section 42 leads to the mainhelical section 44. The main helical section 44, when viewed in an endview such as in FIG. 2C, forms a generally 360 degree circular form,with the central axis 46 of the helical 360-degree pattern of the mainhelical section 44 aligned with the central axis 48 of the main body 22.Note that the 360 degree helical needle is only one embodiment of theinvention. For example, the helical needle may define a path thatencompasses more than 360 degrees, or less than 360 degrees, dependingon the particular application. In one embodiment, the helical needlepasses through a partial circular path defining only 270 degrees or evenless.

The main body 22 may include a seal to prevent and/or otherwise controlthe passage of fluids and or other material(s) through the inner lumen24. In the example of FIGS. 2A-2D, the main body 22 includes a siliconwasher 50 fitted within the main body proximal end 52. The siliconwasher 50 has an internal opening 54. The main body proximal end 52includes a threaded fitting 56 which can accommodate a cap 58 having amatching thread. The cap 58 is screwed onto the threaded fitting 56. Asthe cap 58 is advanced (i.e., tightened), it produces inward pressure onthe main body 22 and thus on the outside of the silicon washer 50. Thesilicon washer 50 is thus compressed, reducing the diameter of theinternal opening 54 so that the silicon washer 50 will compress againstanything advanced through the internal opening 54.

The main body 22 may also include a distal ring 55, which may be formedfrom a relatively soft material. The distal ring 55 in the embodimentdepicted helps to secure the helical needle 26 to the main body 22 andmay also act as a padding element to protect the heart tissue. Thedistal ring 55 may extend distally from the rest of the main body 22, sothat it would define the distal-most portion of the device other thanthe helical screw, and thus provide extra padding when the device isplaced against the heart wall.

As depicted in FIGS. 3A-3C, a further element is a puncture needleassembly 60, which includes a puncture needle 62. The puncture needle 62may have a sharp distal tip 64 and/or a flared proximal end 66. In anembodiment of the invention, the puncture needle is an 18-gauge hypotubehaving a length of about 3-4.5 inches, which is sufficient to passthrough the wall of a human heart. A female luer 72 is secured to theproximal end 74 of the single lumen tube 70. In the particularembodiment depicted, the needle 62 is bonded to or otherwise lies withinthe entire length of body 70, with the flared proximal end 66 residingat the luer 72.

The puncture needle 62 includes an inner lumen 76 and distal opening 77.The luer lock includes a proximal opening 79. The puncture needle lumen76, puncture needle distal opening 77, and luer lock proximal opening 79each has sufficient diameter to accommodate a guide wire, such as a0.035 inch guide wire. The puncture needle assembly 60 is thus sized andconfigured to permit a guide wire (not shown in FIGS. 3A-3C) to beintroduced through the luer lock proximal opening 79, advanced throughthe puncture needle inner lumen 76, and out the puncture needle distalopening 77.

As depicted in FIGS. 4A-4B, the puncture needle assembly 60 can beadvanced through the inner lumen 24 of the device 20 until the punctureneedle distal tip 64 extends distally from the device main body 22 anddistally past the helical needle 26. Note that the puncture needleassembly 60 can even be advanced further than shown, depending on theparticular application, such that the puncture needle body 70 alsoextends distally at least partially from the device main body 22. Luer72 may have too large an outer diameter to pass through the main bodylumen 24, and will instead engage against the cap 58 and/or main bodyproximal end 52 to prevent the puncture needle assembly 60 from beingadvanced too far through the device 20. The lumen tube 70 fits tightlywithin the opening in the washer 50, so that when the cap 58 istightened the washer 50 engages inwardly against the lumen tube 70 tohold the puncture needle assembly 60 and/or to form a tight seal betweenthe puncture needle assembly/lumen tube 70 and the device main body 22.Such a tight seal may prevent and/or otherwise control the passage offluids therethrough.

FIG. 5A illustrates a stabilizer device 20 according to an embodiment ofthe invention placed adjacent the heart 14 at the left ventricular apex16 thereof. The heart 14 includes a heart wall 82, left ventricle 84,aortic valve 86, aortic valve leaflets 88, aortic valve annulus 90, andaorta 92. The puncture needle 62 is advanced distally from the body 22of the stabilizer device 20, creating a puncture 94 in the heart wall 82at the apex 16. The puncture needle 62 is passed through the heart wall82 and into the left ventricle 84. The puncture needle 62 has a lengthsufficient to pass through the heart wall 82 adjacent the apex 16. Themain body 22 of the stabilizer device 20 may have sufficient length toreach from the heart apex to the position adjacent to and/or justoutside of the intercostal access incision or other access point intothe patient.

FIG. 5B illustrates a guidewire 96 being advanced through the stabilizerdevice 20 and puncture needle 62. The guidewire 96 is advanced throughthe left ventricle 84 and through the aortic valve annulus 90 until theguidewire distal end 98 is positioned in the aorta 92. In a preferredembodiment, the guide wire 96 has sufficient length to reach from theoutside of the patient (adjacent the intercostal access incision orother access point) and into the aorta 92 via the heart apex 16. In oneembodiment of the invention, the guidewire is a 0.035″ diameterguidewire.

FIG. 5C depicts the helical needle 26 of the stabilizer device 20 beingadvanced into the heart wall 82 adjacent the apex 16. The surgeon orother user can grasp and apply forward force to the main body 22 of thestabilizer device 20 in order to press the distal tip 36 of the helicalneedle assembly against the apex 16, and simultaneously rotate the mainbody 22 of the stabilizer device 20 in order to rotate the helicalneedle 26 with respect to the heart 14. The rotation may be a partialrotation of about 270 degrees, although a full rotation of about 360degrees (or more) may be preferable, depending on the particularapplication and/or characteristics of the specific stabilizer beingused. The forward pressure and rotation of the helical needle 26advances the helical needle 26, in screw-like fashion, into the heartwall 82. As the helical needle 26 advances into the heart wall 82, itfollows a helical path around the puncture needle 62 and puncture 94(i.e., with the puncture needle 62 and puncture 94 generally alignedwith the central axis of the helical needle 26).

While the embodiments described above envision the helical needle 26 tohave a detachable sharp tip, the invention is not limited to suchembodiments. For example, a sharpened distal tip may be formed as anintegral part of the helical needle (e.g., by sharpening the distal endof the hypotube) or as separate element, e.g., an inner needle with asharp tip that can extend from within the helical needle (as depicted inFIG. 6), and/or a detachable sharp tip positioned at the distal end ofthe hypotube that forms of the helical needed (as depicted in FIGS.2A-2D).

In one embodiment of the invention, after or as the helical needle isrotated into the heart wall 82, the distal end of the helical needle 26is advanced back out of the heart wall 82 so that the surgeon or otheruser can grasp the distal portion 34 of the suture 30 in order to formthe full purse-string. For example, when the helical needle 26 has beenrotated about 360 degrees in screw-like fashion in the heart wall 82,the distal end of the helical needle 26 (such as the detachable distaltip 28 of FIGS. 2A-2D) can be advanced back out of the heart wall 82 ata position at or adjacent the position where the helical needle 26 firstentered the heart wall 82, such as in the embodiment depicted in FIG. 7.

Advancing the distal end of the helical needle 26 out of the heart wall82 may be achieved by various methods, depending on the particularapplication. For example, simply angling the entire instrument 20 cancause the distal end of the helical needle 26 to be directed in agenerally proximal direction and back out of the heart wall 82. However,in other embodiments (which may be useful in circumstances such as wherethe tissue is somewhat fragile), a wire guide or deflection mechanismmay be provided to assist the redirection of the helical needle distalend and/or suture distal portion. For example, in another embodiment ofthe invention, as depicted in FIG. 6, the helical needle 26 includes aninner needle 100 coaxially placed inside the helical needle 26. Theinner needle 100 may be formed of a shape memory material, e.g., it maybe made from a high elasticity material such as Nitinol. The innerneedle 100 may be formed with a “programmed” shape generally the same asthe helical needle 26, so as to slide more easily therein, but a distalportion 102 (e.g., about the last 1 inch) of the inner needle 100 mayhave a “memory” curve of about 90 degrees. Accordingly, when the innerneedle distal portion 102 is advanced out of the distal end of thehelical needle 26, the inner needle distal portion 102 (with the suturedistal portion 34 extending from and/or secured to the inner needledistal portion 102) will turn back toward the main body 22 of the device20, and thus advance back out of the heart wall 82 toward the devicemain body 22. Such an assembly is similar to that depicted in FIGS.18A-B and 19A-19B of co-pending U.S. patent application Ser. No.12/844,139, entitled “Surgical Puncture Cinch and Closure System,” filedJul. 27, 2010, the entire contents of each of which are expresslyincorporated herein by reference.

With the suture distal portion 34 extending from, and/or otherwiseadvanced out of, the helical needle distal end and out of the heartwall, the surgeon or other user can then grasp the suture distal portion34, such as by using a pair of forceps. Once the surgeon or other userhas grasped the distal portion 34 of the suture 30, that distal portion34 can be pulled away from the heart apex 16 and secured to a desiredlocation. For example, the distal portion 34 could be pulled back out ofthe patient and temporarily secured to a desired location, such as anexterior surface of the patient (e.g., the patient's skin) at a locationadjacent the incision. The suture 30 will thus pass from the device mainbody 22, through the helical needle 26 to follow a generally circularpath through the heart wall and around the puncture 94 in the apex 16,and out of the patient.

With the stabilizer device 20 secured firmly to the heart apex 16 viathe helical needle 26, and with the distal portion 34 of the suture 30secured to the outside of the patient, the puncture needle 62 iswithdrawn from the heart 14 and from the stabilizer device main body 22,as depicted in FIG. 7. The stabilizer device 20 remains secured to theheart wall 82 and the guide wire 96 remains in place within the heart14.

With the stabilizer 20 secured to the heart 14, the desired proceduremay be performed within the interior of the heart 14. In one example ofsuch a procedure, depicted in FIGS. 8A-8D, a prosthetic heart valve 110is deployed in the heart 14. As seen in FIG. 8A, a sheath 112 isadvanced into the heart 14 through the stabilizer device 20 and apicalpuncture 94 to a desired location within the ventricle 84. A deploymentcatheter 114 extends from the sheath. The distal portion of thedeployment catheter 114 has an expandable balloon 116, and an expandableprosthetic heart valve 110 is positioned on the expandable balloon. Asdepicted in FIG. 8B, the deployment catheter 114 is advanced andmaneuvered such that the expandable balloon 116 and expandableprosthetic heart valve 110 are at a desired position, which in FIG. 8Bis a position between the valve leaflets 88 and within the valve annulus90. With the deployment catheter 114 and prosthetic heart valve 110 atthe desired position, the prosthetic heart valve 110 is expanded intocontact with the tissue of the valve annulus and leaflets 88, with theexisting valve leaflets 88 pressed between the expandable prostheticheart valve 110 and the valve annulus 90. Expansion of the prostheticheart valve 110 is accomplished by expanding the expandable balloon 116,as depicted in FIG. 8C. After the prosthetic heart valve 110 isdeployed, the balloon 116 is deflated, and the deployment catheter 114and sheath 112 are withdrawn from the patient.

Note that other medical devices and procedures may also be used with thestabilizer. For example, the prosthetic heart valve could be aself-expanding heart valve (such as a prosthetic heart valve having asupport stent made of a memory material such as Nitinol), and thecatheter may include a retractable sleeve that initially restrains theself-expanding heart valve but is then withdrawn to release theself-expanding heart valve, whereupon the self-expanding heart valveexpands into the desired position, e.g., into contact with the valveannulus and/or leaflets. As another example, the catheter may be asuturing catheter configured to deliver a first end of suture through anative valve leaflet and deliver a second end of the suture throughpapillary muscles in order to create artificial chordae.

Details of an exemplary procedure for implanting a prosthetic heartvalve (and which could be used in conjunction with the stabilizerdevices and methods disclosed herein) are included in U.S. patentapplication Ser. No. 12/835,546, filed Jul. 13, 2010 and entitled“Transapical Delivery System for Heart Valves,” and in U.S. patentapplication Ser. No. 12/835,555, filed Jul. 13, 2010 and entitled“Transapical Delivery System for Heart Valves,” the contents of each ofwhich are expressly incorporated herein in their entirety.

The devices and methods disclosed herein could also be used with variousother medical instruments and devices. For example, the device depictedin FIGS. 2A-4B could be used with a device stabilizer, such as thatdisclosed in U.S. Provisional Patent Application No. 61/229,675 filedJul. 29, 2009 and entitled “Intracardiac Sheath Stabilizer,” and in U.S.patent application Ser. No. 12/845,584, filed Jul. 28, 2010 and entitled“Intracardiac Sheath Stabilizer,” the contents of each of which areexpressly incorporated hereby in their entirety. For example, in FIG.9A, a port-access stabilizer 120 has a base 122 secured to the patientadjacent the intercostal incision 12 (or other opening into a patient).The port-access stabilizer 120 has an articulated arm 124 with a cuff126 which holds a sheath 128, with the sheath 128 advanced through thestabilizer device 20 and into the heart 14. The stabilizer arm 124 thusstabilizes the sheath 128, thereby also providing some stability for thestabilizer device 20. If the sheath 128 or other instrument wererelatively restrained longitudinally with respect to the stabilizerdevice 20 (e.g., where the washer 50 of FIGS. 2B and 4B was pressedinward by tightening of the cap 58 to prevent the sheath from sliding),the stabilizer device 20 would thus be restrained against lateral(side-to-side) movement as well as longitudinal (distal/proximal)movement. If the sheath 128 or other instrument were relativelyunrestrained longitudinally with the stabilizer device 20 (e.g., wherethe washer 50 of FIGS. 2B and 4B was not compressed against the sheath),the stabilizer device 20 would only be restrained against lateral(side-to-side) movement, thus permitting the sheath 128 to be heldstable while allowing the stabilizer device 20 to move longitudinallyresponsive to similar longitudinal movement of the heart apex resultingfrom the beating of the heart.

In another example depicted in FIG. 9B, the stabilizer arm 124 and cuff126 is secured to the stabilizer device 20 of the invention in order tohold the stabilizer device 20 itself securely in a desired potion. Ifthe sheath 128 or other instrument were relatively restrainedlongitudinally with respect to the stabilizer device 20 (e.g., where thewasher 50 of FIGS. 2B and 4B were pressed inward by tightening of thecap 58 to prevent the sheath from sliding), the sheath 128 would thus berestrained against lateral (side-to-side) movement as well aslongitudinal (distal/proximal) movement. If the sheath 128 or otherinstrument were relatively unrestrained longitudinally with thestabilizer device 20 (e.g., where the washer 50 of FIGS. 2B and 4B werenot compressed against the sheath), the stabilizer device 20 would onlybe restrained against lateral (side-to-side) movement, thus permittingthe stabilizer device 20 to be held stable while the sheath 128 couldmove longitudinally responsive to similar longitudinal movement of thetarget area of treatment within the heart.

In a further embodiment of the invention, a multiple-arm outsidestabilizer could be used, such as the type depicted in FIGS. 14-18 ofU.S. patent application Ser. No. 12/845,584. One stabilizer arm could beused to hold the stabilizer device 20, while another stabilizer armcould be used to hold the sheath 128 or other medical device.Accordingly, both the stabilizer device 20 and any medical deviceadvanced therethrough would be firmly held in a desired position.

Once the desired procedure has been performed on the interior of theheart (such as the prosthetic heart valve deployment depicted in FIGS.8A-8D), the device 20 is removed from the heart wall 82, as depicted inFIGS. 10A and 10B. To remove the helical needle 26 from the heart wall82, the surgeon or other use rotates the device main body 22 to“unscrew” the device from the heart wall 82 about the apical puncture94. For example, if the helical needle of the device was advanced intothe heart wall by rotating the device in a clockwise direction, the userwill now rotate the device in a counter-clockwise direction to removethe helical needle from the heart wall.

While holding the suture distal portion 34 (or with the suture distalportion otherwise secured, e.g., as by being sutured to the patient at aposition outside the intercostal incision), the suture needle 26 isrotated in the opposite direction to reverse its path through thetissue. The length of suture 30 pays out from the stabilizer device 20.Once the helical needle 26 is completely out of the heart wall 82, thestabilizer device 20 is removed from the patient. Two free ends of thesuture 30 (which could be single- or multi-stranded suture) extend fromthe entry point 130 and the exit point 132. As depicted in FIG. 10B,tensioning the suture 30 closes the apical puncture 94. The tensionedsuture 30 can be secured with a knot or other securing technique/device.For example, pledgets 134, 136 may be added to the suture 30, which isthen pulled tight and knotted adjacent the pledgets to close thepuncture 94.

While the invention has been described in various embodiments, it is tobe understood that the words which have been used are words ofdescription and not of limitation. Therefore, changes may be made withinthe appended claims without departing from the true scope of theinvention.

What is claimed is:
 1. A system for performing a procedure on a heart,comprising; a stabilizer, comprising: a handle comprising a proximalend, a distal end, and a handle body, the handle further comprising aproximal opening, a distal opening, and an access lumen passing throughthe handle body and extending from the proximal opening to the distalopening; a helical needle extending from a distal end of the handle, thehelical needle comprising a helical distal portion and a distal end,wherein the helical needle extends from a side of the distal end of thehandle, the helical distal portion circumscribing a longitudinal axis ofthe access lumen without obstructing the handle distal opening; a lengthof suture along the helical distal portion of the helical needle; and apuncture implement comprising a proximal portion and a distal portion,wherein the distal portion comprises a sharp needle, wherein thepuncture implement is positioned slidingly within the access lumen ofthe handle of the stabilizer with the sharp needle in longitudinalalignment with the longitudinal axis of the access lumen.
 2. The systemof claim 11, wherein the helical needle comprises a deflection segmentpositioned at or within the distal portion of the helical needle, andwherein the length of suture passes through the helical needle to thedeflection segment.
 3. The system of claim 12, wherein the deflectionsegment is more flexible than the rest of the helical needle.
 4. Thesystem of claim 11, wherein the stabilizer further comprises a paddeddistal portion at the distal end of the handle.
 5. The system of claim11, wherein the stabilizer further comprises: a seal configured toengage against the puncture device to prevent the passage of fluidthrough the access lumen and between the puncture device and thestabilizer handle.
 6. The system of claim 11, wherein the punctureimplement comprises an inner lumen passing the length of the punctureimplement, wherein the inner lumen is configured to slidingly receive aguide wire.
 7. A stabilizer comprising: a handle comprising a proximalend, a distal end, and a handle body, the handle further comprising aproximal opening, a distal opening, and an access lumen passing throughthe handle body and extending from the proximal opening to the distalopening; an annular sealing ring positioned within the access lumen,wherein the annular sealing ring is configured to engage inwardlyagainst devices passing through the access lumen; a helical needleextending from a distal end of the handle, the helical needle comprisinga helical distal portion and a distal end, wherein the helical needleextends from a side of the distal end of the handle, the helical distalportion circumscribing a longitudinal axis of the access lumen withoutobstructing the handle distal opening; and a length of suture passingalong the helical distal portion of the helical needle.
 8. Thestabilizer of claim 17, wherein the access lumen has an inner diameterof about 0.25-0.50 inches.
 9. The stabilizer of claim 17, wherein thestabilizer has a length of about 2-4 inches.
 10. The stabilizer of claim17, further comprising a threaded fitting on the handle, and furthercomprising a cap having a matching thread to the threaded fitting,wherein the cap positioned on the threaded fitting and configured to beadvanced, in screw-like fashion, over the threaded fitting and tothereby produce inward pressure on the handle.